HEALTH CARE BRIEFING: Lab Test Language Floated to Join FDA Bill


By Michaela Ross

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Lawmakers behind a bill to revamp diagnostics regulation are eyeing FDA user fee legislation as a vehicle for pushing their proposal across the finish line.

“The time for Congress to clarify the rules of the road for diagnostic testing is now,” Rep. Larry Bucshon (R-Ind.) said yesterday during a Friends of Cancer Research event. He and Rep. Diana DeGette (D-Colo.) are working to advance their measure, nearly a decade in the making, “on its own or attached to must-pass bills like MDUFA,” the next iteration of the Medical Device User Fee Amendments that’s up for renewal this year.

Their bill, known as the VALID Act (H.R. 4128), would establish a new framework for the Food and Drug Administration to regulate diagnostic tests. It would create a category of medical products called in vitro diagnostic tests, instead of keeping them as a subcategory within device regulations. That would allow the FDA to oversee tests regardless of whether they came from clinical laboratories or from commercial companies.

A companion bill (S. 2209) has also been introduced in the Senate. Neither bill has seen action, but legislation dictating the rates that device makers pay the agency often includes policy riders that go beyond user fees and presents a fresh opportunity for the VALID Act. Congress must pass a law adopting the next iteration of device user fees for fiscal years 2023 through 2027 before the current one expires Sept. 30.

“This year is a pivotal year for VALID, and I look forward to continuing to work with you all to help get it across the finish line so that we can provide certainty to patients and modernize regulatory oversight of in vitro diagnostic tests to better promote innovation and advancements,” Bucshon said. Read more from Jeannie Baumann.

Happening on the Hill

Bill Aims to Help Veteran Health Benefits: A bid to help U.S. veterans exposed to toxic substances during deployments to Iraq and Afghanistan faces objections to its cost as backers of the ambitious legislation prepare for a vote in the House next week. The bill (H.R. 3967) would speed health care and benefits to millions of veterans exposed to burn pits. Some Republicans say the price tag—almost $300 billion over the next decade—is too high.

The military long has used open air pits to burn jet fuel, paint, plastic, medical waste, and garbage. Veterans diagnosed with cancer, lung disease, and other respiratory problems years after their deployments have sought help for the ailments they suspect were caused by the toxic exposure. “This is about the cost of war,” bill sponsor Mark Takano (D-Calif.), chair of the House Veterans’ Affairs Committee, said at a roundtable. Congress cannot renege on its promises to those who fought the country’s wars “because of sticker shock,” he added.

Roughly 3.5 million veterans have had some burn pit exposure, lawmakers and advocates estimate. Still, the Veterans Affairs Department doesn’t recognize the effects of burn pits as conditions it should cover, and says there’s insufficient evidence to support such claims. Takano’s bill would shift the burden of proof, giving veterans the benefit of the doubt when they seek help from the VA. It also would establish a presumption of connection between 23 respiratory illnesses and cancers and service personnel’s exposure to burn pits and airborne hazards. Read more from Roxana Tiron.

  • Meanwhile, the U.S. Supreme Court will decide whether veterans can get around a one-year filing deadline for disability benefits, or whether courts are barred from considering any deviation from the strict rule. The justices agreed yesterday to resolve the dispute that divided the full U.S. Court of Appeals for the Federal Circuit. Petitioner Navy veteran Adolfo Arellano said resolving the issue “is important to tens of thousands of current and future military veterans” whose service-related mental and physical disabilities can make it difficult to meet the one-year deadline, Kimberly Strawbridge Robinson reports.

The Coronavirus Pandemic

Full Vaccine Approvals Seen as Boon for Post-Pandemic: U.S. availability of two fully approved Covid-19 shots sets the stage for normalizing vaccination post-pandemic and could beef up incentives for remaining holdouts, health policy professionals say. Moderna’s Spikevax joins the ranks of Pfizer and BioNTech’s Comirnaty as the second Covid-19 vaccine approved by the FDA and recommended by the CDC. Lingering vaccine hesitancy means the country won’t see an immediate uptick in inoculation rates, but the government’s latest action could still ease distribution challenges, encourage more employers to offer boosters, and eventually sway Americans who are leery to get the shot. Read more from Ian Lopez.

  • Meanwhile, the U.S. Supreme Court refused to consider requiring that government-imposed Covid-19 vaccine mandates include religious exemptions, turning away an appeal by a group of Maine health-care workers. Although the Supreme Court has limited the federal government’s power to require Covid-19 shots or tests, the justices have allowed state and local mandates, even without religious exemptions. Read more from Greg Stohr.

Covid-19 Suit Against Nursing Home Must Go Back to State Court: Wrongful death and injury claims against nursing homes that allegedly failed to protect residents from Covid-19 belong in state court because federal law doesn’t require them to be heard exclusively in federal courts, the Ninth Circuit said yesterday. A similar case involving Texas-based nursing homes is pending in the U.S. Court of Appeals for the Fifth Circuit. The issues involved are likely to go to the U.S. Supreme Court, especially if the Fifth Circuit case goes the other way. Read more from Mary Anne Pazanowski.

New Infections in U.S. Slow to Pre-Omicron Level: The seven-day average of new cases in the U.S. fell to 89,024 Monday, the lowest since Dec. 1 and the spread of the highly transmissible omicron variant, according to a database maintained by the New York Times. Read more from Bloomberg News.

Flight Attendants Expect Mask Rule to Be Extended: The largest union representing U.S. flight attendants expects a federal order mandating face masks for air passengers and other travelers will be extended again, even as a growing number of states and businesses lift restrictions. The requirement is set to expire on March 18 after being extended three times since it first was imposed in February 2021 as a way to stem the spread of Covid-19. Read more from Mary Schlangenstein.

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What Else to Know

Abortion Provider’s Standing Confirmed in Six-Week Law Challenge: A Planned Parenthood affiliate can sue South Carolina to invalidate a law banning abortions at about six weeks because it may properly assert its patients’ constitutional rights, the Fourth Circuit said yesterday. The underlying issue here is the constitutionality of a state law that prohibits abortions after cardiac activity is detected, which usually occurs at about the six-week mark. The law is similar to one in Texas to the extent that it would put a stop to most abortions in the state, according to Planned Parenthood data. Read more from Mary Anne Pazanowski.

Pharmacy Liaison Probe Said Must Be More ‘Rigorous’: FTC Commissioner Noah J. Phillips said he supports probing the entities that manage prescription drug coverage for insurers, but that the proposed study he voted against launching wasn’t “rigorous” enough to attract his support. Phillips, one of two Republicans on the Federal Trade Commission, told Bloomberg Law that the proposal to look into pharmacy benefit managers didn’t clarify what exactly the agency would review and whether it would account for consumer drug costs. Read more from Celine Castronuovo.

Medical Pot for Work Injury Spurs High Court to Seek DOJ’s Views: The U.S. Supreme Court asked the Justice Department to weigh in on whether federal law prohibiting cannabis trumps a state workers’ compensation law calling on employers to reimburse injured workers for medical marijuana costs. The justices asked for the solicitor general’s views in a pair of cases challenging Minnesota Supreme Court rulings that the Controlled Substances Act preempted orders requiring reimbursement for medically prescribed cannabis. The issue has divided state high courts. Read more from Robert Iafolla.

Medical Device Quality Rules to Match World Norms: The FDA is proposing to align its quality standards for medical devices with those used by regulatory bodies across the globe. The proposed rule (RIN 0910-AH99), released yesterday, seeks to harmonize standards for manufacturing, storing, and distributing devices, which the Food and Drug Administration says would give patients “more efficient access to necessary devices” and lead to improved quality of life for consumers. Read more from Celine Castronuovo.

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To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Brandon Lee at blee@bgov.com

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